GLS-1200Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19) in Health Care Personnel

Overview

This clinical trial will evaluate the safety, tolerability and effectiveness of topical GLS-1200 nasal spray to reduce the incidence of confirmed, symptomatic SARS-CoV-2 infection.

Full Title of Study: “Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection in Healthcare Personnel”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: September 2020

Detailed Description

This Phase II randomized, placebo-controlled, double-blind study will assess whether topical GLS-1200 applied via nasal spray atomizer is well-tolerated and can reduce the incidence of confirmed SARS-CoV-2 infection. Subjects will be randomized to either the GLS-1200 or placebo group in a 2:1 ratio with a target enrollment of 225 subjects. Subjects will self-administer study drug three times daily for 4 weeks.

Interventions

  • Drug: GLS-1200
    • GLS-1200 is given as a nasal spray using an atomizer
  • Drug: Placebo
    • Placebo is given as a nasal spray using an atomizer

Arms, Groups and Cohorts

  • Experimental: GLS-1200
    • 1 mL of GLS-1200 per nostril, TID
  • Placebo Comparator: 0.9 %Saline
    • 1 mL of 0.9% Saline per nostril, TID

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate the number of GLS-1200 topical nasal spray adverse events as assessed by CTCAE v5.0
    • Time Frame: 4 weeks of treatment
  • Incidence of SARS-CoV-2 infection, confirmed by PCR relative to treatment group
    • Time Frame: 4 weeks of treatment

Secondary Measures

  • Symptom score of documented SARS-CoV-2 infection relative to treatment group with a higher score being a worse outcome.
    • Time Frame: 4 weeks of treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18 or older
  • Able to provide informed consent
  • Able and willing to comply with study procedures
  • Adult healthcare professional

Exclusion Criteria

  • Know allergy to quinine, quinidine, or mefloquine
  • Confirmed prior positive test for SARS-CoV-2
  • Treatment within the past 2 weeks with chloroquine, hydroxychloroquine, or remdesivir

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GeneOne Life Science, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Medical Monitor, 484-965-9147, jmaslow@geneonels-us.com

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